Randomized, Open, Parallel Group Study for the Evaluation of an Oral Dose of 100 mg Thalidomide and Subsequent Dose Escalation of 400 mg Thalidomide in Combination With Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)
Study drug will be provided as 50 mg tablets. Patients will be instructed to take 2 tablets
orally once a day during the evening at least 60 minutes after a meal. Thalidomide will be
administered starting at 100 mg (Group 1) for 6 weeks. Thereafter, the dose will be
increased every week by 50mg until reaching the dose of 400 mg/day. This treatment is
continued for 12 weeks. Thalidomide is administered in conjunction with the standard
treatment of riluzole (100mg/day).
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
to evaluate the long-term safety and tolerability of thalidomide
Thomas Meyer, MD
Study Chair
Charité University Hospital, Berlin, Germany
Germany: Federal Institute for Drugs and Medical Devices
THL-ALS01
NCT00231140
December 2005
August 2006
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